FDA Recalls Compounded Hydroxocobalamin Injectable Solution Due to Sterility Concerns
The FDA is recalling compounded hydroxocobalamin injectable solution from Moses Lake Professional Pharmacy due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Hydroxocobalamin (Compounded) Injectable Solution, 1 mg/mL, 30 mL syringe. The product is recalled by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington.
The recall is being conducted because of a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within expiry are affected by this issue. The recall is classified as Class II by the FDA.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling pharmacy for instructions on how to return or dispose of the medication. The product was distributed nationwide.
The recalled product
- Product
- HYDROXOCOBALAMIN (COMPOUNDED), Injectable Solution, 1 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Category
- Drug — Compounded Injectable
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- t10032014@12
- t11032014@18
- t02022015@4
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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